System and method for removing an implanted catheter from a patient

ABSTRACT

A method comprising removing a port from a patient through an incision and coupling a rod disposed in a sheath to the end of a catheter. The method also includes sliding the sheath along the rod and catheter into tissue surrounding the catheter in a rotating manner to separate the tissue from the catheter until the catheter is able to freely be removed from the patient, and removing the catheter from the patient. The method may also include making a shorter second incision on the patient and exposing a portion of the catheter through the patient&#39;s skin to facilitate coupling of the rod with the catheter and retrieval of the catheter.

BACKGROUND

Numerous companies manufacture devices which enable medicines to beinjected into a patient directly into the bloodstream and enable samplesof blood to be taken from the patient. Other similar devices andcatheters may be inserted for long-term dialysis or intravenous feeding.These devices are sometimes termed port-a-caths, infusa-ports, andvenous access devices. Two manufacturers of these devices are C. R.Bard, Inc. and AngioDynamics. These devices often consist of a port,which also may be referred to as a drum, and a catheter which is coupledto the port. The catheter is typically inserted into a major vein,leading to a central vein, in the patient. Thus, the medicine isinjected with a syringe, using a special needle, through the patient'sskin directly into the port and carried directly into the patient'sbloodstream through the catheter. Dialysis and feeding catheters are notusually coupled to a port, but come out through the skin. The section ofthe catheter outside the skin has a closure mechanism to keep thecatheter shut and sterile when not in use. Just within the skin, adialysis catheter has a Dacron cuff which anchors the catheter to thetissues and acts as a bacteriostatic bacterial barrier. All of thesedevices are usually intended to be implanted into the patient for longperiods of time, e.g. months or even years. During this time, tissue maybuild up along the catheter and adhere to the catheter, both inside thevessel, along the tract, and outside the vessel, so that it may not bepossible to remove the catheter without damaging the blood vesselcausing serious, life-threatening bleeding. Accordingly, removingcatheters that have been implanted for a long time may be problematic,and the present common practice, as advised by the manufacturer of thesedevices, is to leave the catheter in place indefinitely.

SUMMARY

The problems noted above are solved in large part by a system and methodfor removing an implanted port system and associated catheter from apatient. In some embodiments, the method comprises making a firstincision on a patient, removing a port from the patient, and coupling arod disposed in a sheath to a catheter. The method also includes slidingthe sheath along the rod and catheter into tissue surrounding thecatheter in a rotating manner to separate the tissue from the catheteruntil the catheter is able to freely be removed from the patient, andremoving the catheter from the patient. In some embodiments, the methodmay also include making a second incision on the patient that is shorterthan the first incision and closer to the blood vessel exposing aportion of the catheter through the patient's skin and delivering thedistal portion of the catheter outside the skin. In the case of thedialysis catheter, the catheter is cut at the Dacron cuff then treatedsimilarly.

Another illustrative embodiment includes a system for removing animplanted port system and associated catheter that comprises a rodcontaining a rod body and a rod handle. The rod handle is substantiallystraight. The system also comprises a hollow sheath containing a sheathbody and a sheath handle. The sheath body is capable of bending to atleast 90 degrees. The sheath body may not have a longitudinal rip apartseam embedded along its length and also may not have a valve. Both therod handle and the sheath handle are made of a non-slip material. Thehollow sheath's inner diameter may be approximately the diameter of acatheter that has been implanted into a patient.

Yet another illustrative embodiment includes a system for removing animplanted port system and associated catheter comprising means forcoupling a rod to a catheter. The system also includes a means forseparating tissue from the catheter so that the catheter is able tofreely be removed from a patient.

BRIEF DESCRIPTION OF THE DRAWINGS

For a detailed description of various disclosed embodiments, referencewill now be made to the accompanying drawings in which:

FIG. 1 shows a detailed view of a rod which may be used in removing aport-a-cath from a patient, in accordance with various embodiments ofthe invention;

FIGS. 2 a, 2 b, and 2 c show detailed views of a sheath which may beused in removing a port-a-cath from a patient, in accordance withvarious embodiments of the invention;

FIG. 3 shows a patient in whom a port and catheter have been implantedin accordance with various embodiments of the invention;

FIG. 4 shows a patient on whom an incision is made to remove a port, inaccordance with various embodiments of the invention;

FIG. 5 shows a patient in which a port has been removed but a catheterremains implanted, in accordance with various embodiments of theinvention;

FIG. 6 shows a sheath and a rod for removing a catheter from a patient,in accordance with various embodiments of the invention; and

FIG. 7 shows an illustrative flow diagram of a method implemented inaccordance with embodiments of the invention.

NOTATION AND NOMENCLATURE

Certain terms are used throughout the following description and claimsto refer to particular system components. As one skilled in the art willappreciate, companies may refer to a component by different names. Thisdocument does not intend to distinguish between components that differin name but not function. In the following discussion and in the claims,the terms “including” and “comprising” are used in an open-endedfashion, and thus should be interpreted to mean “including, but notlimited to . . . .” Also, the term “couple” or “couples” is intended tomean either an indirect or direct mechanical connection. Thus, if afirst device couples to a second device, that connection may be througha direct connection, or through an indirect connection via other devicesand connections.

DETAILED DESCRIPTION

The following discussion is directed to various embodiments of theinvention. Although one or more of these embodiments may be preferred,the embodiments disclosed should not be interpreted, or otherwise used,as limiting the scope of the disclosure, including the claims. Inaddition, one skilled in the art will understand that the followingdescription has broad application, and the discussion of any embodimentis meant only to be exemplary of that embodiment, and not intended tosuggest that the scope of the disclosure, including the claims, islimited to that embodiment.

FIG. 1 shows a detailed view of a rod 100 which may be used in removinga port-a-cath from a patient, in accordance with various embodiments ofthe invention. Rod 100 is comprised of rod body 102, rod handle 104, andthreaded end 106. Rod body 102 is substantially straight. In at leastsome embodiments, “substantially straight” means straight plus or minusthree degrees. Rod body 102 preferably is smooth, so that a sheath mayslide along rod body 102 easily. Rod body 102 is approximately 2millimeters in diameter, and approximately 19 centimeters in length,although it may be more or less in both diameter and length. Rod body102 may be manufactured with a metal material; however, it may also beany material that remains rigid under tension.

Rod handle 104 may be 5 millimeters in diameter and two centimeters inlength; however, other lengths and diameters may also be used. Rodhandle 104 preferably is manufactured of a non-slip material. That is,rod handle 104 is manufactured with a material that will not slip in aphysician's hand when rod handle 104 has body fluid (e.g. blood) on itssurface. Some such materials include materials with a relatively highcoefficient of friction compared to rod body 102's material, e.g.rubber, or a textured metal or plastic surface, e.g. ridged, knurled, ornotched.

Threaded end 106 may have any diameter which allows it to be screwedinto the end of a catheter. In some embodiments the diameter of threadedend 106 may be 1.35 millimeters. Preferably, the diameter of threadedend 106 is as small as possible so that the catheter does not bulge, butit should still be able to engage a catheter firmly and securely.Threaded end 106 may be 1 centimeter in length, although the length mayvary.

FIGS. 2 a, 2 b, and 2 c show detailed views of a sheath 200 which may beused with rod 100 in removing a port-a-cath from a patient, inaccordance with various embodiments of the invention. FIG. 2 a shows adetailed view of sheath 200 as viewed as a whole, in accordance withvarious embodiments of the invention. Sheath 200 is comprised of sheathbody 202 and sheath handle 204. Sheath body 202 may be fifteencentimeters in length, but may also be shorter or longer. Sheath body202 is typically shorter than rod body 102 from FIG. 1. Sheath body 202may be made of an opaque plastic material or a metal, e.g. coil wire, sothat it is visible in x-rays and during fluoroscopy. Sheath body 202also typically is bendable up to 90 degrees to enable sheath 200 tofollow any bends in the catheter without damaging the catheter. Whilemany prior art sheaths have longitudinal rip apart seams embedded alongtheir lengths, in some embodiments sheath body 202 does not contain anylongitudinal rip seams. In other embodiments, sheath body 202 does haverip seams. Additionally, many prior art sheaths have a stop valve neartheir ends. However, in some embodiments sheath 200 does not contain astop valve. The outer diameter of sheath body 202 is usually 4millimeters, 3.7 millimeters, or 3.3 millimeters, although otherdiameters would also allow sheath body 202 to implement an embodiment ofthe invention.

While the diameter of sheath handle 204 is typically larger than thediameter of sheath body 202, sheath handle 204 may be any diameter.Sheath handle 204 may be a flared out extension of sheath body 202.Typically, sheath handle 204 is 1 centimeter in length; however, otherlengths may also be used. Sheath handle 204 is manufactured of anon-slip material. That is, sheath handle 204 is manufactured with amaterial that will not slip in a physician's hand when sheath handle 204has body fluid (e.g. blood) on its surface. Some such materials includematerials with a relatively high coefficient of friction compared tosheath body 204′s material, e.g. rubber, or a textured metal or plasticsurface, e.g. ridged, knurled, or notched.

FIGS. 2 b and 2 c show different cross sectional views of sheath 200, inaccordance with various embodiments of the invention. FIG. 2 b shows across sectional view along the entire length of sheath 200. FIG. 2 cshows a cross sectional view of sheath 200 from its end. Sheath 200 is ahollow tube which narrows slightly at the tip. Thus, it has an innerdiameter 206 at its tip as seen in FIG. 2 c. Inner diameter 206 istypically equal to the diameter of a catheter that is intended to beremoved, which may be 2.7 millimeters, 3 millimeters, or 3.3millimeters, so that sheath 200 is capable of separating tissue fromthat catheter.

FIG. 3 shows a patient 300 in whom port 302 and catheter 304,collectively termed a port-a-cath, infusa-port, or venous access device,have been implanted in accordance with various embodiments of theinvention. Catheter 304 is shown inserted into a blood vessel 306. Port302, which also may be referred to as a drum, may be implanted inpatient 300 just beneath the skin. Port 302 is typically implanted inthe chest of patient 300 below the collarbone. However, port 302 may beimplanted elsewhere beneath the skin of patient 300. Port 302 is usually3 to 4 centimeters in diameter; however, it may be any size. Port 302may include a septum, a self sealing rubber or plastic material, so thata special needle may be inserted through the septum into the cavity ofport 302 to obtain blood samples or inject medicine directly into thebloodstream of patient 300 through catheter 304. Catheter 304 is aflexible tube that couples to port 302 and blood vessel 306. Thus,medicine that is injected into port 302 flows directly into blood vessel306 and thence, the bloodstream of patient 300.

Port 302 and catheter 304 are intended to be implanted into patient 300for long periods of time (i.e. weeks, months, or years). During thistime, tissue may build up along and adhere to catheter 304, both insideblood vessel 306 and outside blood vessel 306, so that it is notpossible to safely move catheter 304 without tearing the blood vessel306, causing catastrophic bleeding.

FIGS. 4-6 illustrate an exemplary technique for safely removing catheter304 from patient 300. FIG. 4 shows patient 300 on whom an incision 402is made to remove port 302. Incision 402 is made on patient 300 directlyabove or adjacent to port 302 using a scalpel 404. Incision 402 isusually the same length as is the diameter of port 302, 3 to 4centimeters; however, the length may be any length that would allow port302 to be removed from patient 300. Port 302 is decoupled (e.g. cut orpulled off) from catheter 304 and removed from patient 300 throughincision 402.

In FIG. 5 the port 302 has been removed but the catheter 304 remainsimplanted in patient 300. Preferably another incision 502 is made onpatient 300 using scalpel 304 as close to the point that catheter 304enters blood vessel 306 as possible; however, incision 502 may be madein any location that would allow a length of catheter 304 to be broughtoutside patient 300 for easier handling by the physician making theincision. Incision 502 may be shorter in length than incision 402 fromFIG. 4, and usually is made to be as short as possible, yet large enoughto be able to remove catheter 304 from patient 300. In some embodiments,incision 502 is 0.5 to 1 centimeter in length.

The end of catheter 304 that was decoupled from port 302 is then pulledout through incision 502, so that a section of catheter 304 isprotruding from the body of patient 300. Preferably, at least 2.5centimeters protrudes from the body of patient 300; however, a shortersection of catheter 304 may also protrude from the body of patient 300as well.

FIG. 6 shows sheath 200 and a rod 100 from FIGS. 1 and 2 for removingcatheter 304 from patient 300, in accordance with various embodiments ofthe invention. As discussed previously, rod 100 is a solid cylindricalshaped device comprising rod body 102, rod handle 104, and threaded end106. Sheath 200 comprises sheath body 202 and a sheath handle 204, bothof which are hollow tubes in continuity. Rod 100 is inserted throughsheath 200 and then coupled (e.g. screwed) with the end of catheter 304which is protruding from the body of patient 300. If after screwing rod100 into the end of catheter 304, the end bulges too large to be pulledinto sheath 200, rod 100 may be coupled to catheter 304 within sheath200 by inserting a portion of catheter 304 into sheath 200 and thenscrewing rod 100 into catheter 304 within sheath 200. As mentionedpreviously, during the time catheter 304 has been implanted in patient300, tissue builds up surrounding catheter 304 making it difficult toremove from patient 300. Sheath 200 is slid along rod 100 and catheter304 in a rotating motion to separate the tissue from catheter 304. Atall times, catheter 304 is preferably held taught by maintaining gentletraction on rod 100. Once all of the tissue is separated from catheter304, so that catheter 304 may move freely, catheter 304 is removed frompatient 300.

FIG. 7 shows an illustrative flow diagram of a method 700 implemented inaccordance with various embodiments of the invention. Method 700comprises, in block 702, making an incision above port 302 from FIG. 4.This incision preferably is large enough to enable the removal of port302. The method continues in block 704 with the removal of port 302. Inblock 706, another incision is made near blood vessel 306 in whichcatheter 304, both from FIG. 5, is located. This second incision ispreferably much smaller than the first incision and need only be largeenough to allow the distal part of catheter 304 to be pulled through.Method 700 continues, in block 708, with an end section of catheter 304being pulled through the second incision, so that typically this endsection protrudes at least 2.5 centimeters from the patient's body.

Method 700 also comprises, in block 710, inserting rod 100 through ahollow sheath 200, both from FIGS. 1-2, and coupled to the end ofcatheter 304 which is protruding from the patient's body. Rod 100 istypically coupled with catheter 304 by screwing a threaded end of rod100 into catheter 304. In block 712, sheath 200 is slid along rod 100and catheter 304, which is maintained taught, in a rotating motion toseparate any adherent, built-up tissue from catheter 304.

The method continues, in block 714, with a determination of whethercatheter 304 is free of all surrounding tissue. If catheter 304 iscapable of freely being withdrawn from the patient's body, then it isfree of the surrounding tissue, otherwise, it is not free. If catheter304 is not free of the surrounding tissue, then the method continues inblock 712 with the sliding of sheath 200 along catheter 304 in arotating manner to separate tissue from catheter 304. If however,catheter 304 is free of all surrounding tissue, catheter 304 is removedfrom the patient's body, as illustrated in block 716.

Prior to method 700 it would be prudent to obtain an X-ray film or usefluoroscopy to locate the course of the catheter and position of the tipof the catheter to be removed. Fluoroscopy should also be used to followthe sheath as it advances over the catheter, especially as the sheathapproaches the tip of the catheter.

The above discussion is meant to be illustrative of the principles andvarious embodiments of the present invention. Numerous variations andmodifications will become apparent to those skilled in the art once theabove disclosure is fully appreciated. It is intended that the followingclaims be interpreted to embrace all such variations and modifications.

1-2. (canceled)
 3. A system for removing an implanted cathetercomprising: a rod containing a rod body and a rod handle, wherein therod body is substantially straight; and a hollow sheath containing asheath body and a sheath handle, wherein the sheath body is capable ofbending to at least 90 degrees, and wherein both the rod handle and thesheath handle are made of a non-slip material.
 4. The system of claim 3,wherein the hollow sheath's inner diameter at the tip is approximatelythe diameter of a catheter that has been implanted into a patient. 5.The system of claim 3, wherein the sheath body does not have alongitudinal rip-apart-seam embedded along the sheath body's length. 6.The system of claim 3, wherein the hollow sheath does not have a valve.7. The system of claim 3, wherein the rod handle is constructed of arubber material.
 8. The system of claim 3, wherein the rod handle isconstructed of a textured metal or plastic material.
 9. The system ofclaim 3, wherein the sheath handle is constructed of a rubber material.10. The system of claim 3, wherein the sheath handle is constructed of atextured metal or plastic material.
 11. The system of claim 3, whereinthe rod is at least 22 centimeters in length.
 12. The system of claim 3,wherein the rod's diameter is 1.5 to 2.5 millimeters.
 13. The system ofclaim 3, wherein the hollow sheath is at least 15 centimeters in length.14. A system for removing an implanted catheter comprising: means forcoupling a rod to a catheter; and means for separating tissue from thecatheter so that the catheter is able to freely be removed from apatient.